Stark regulations among new regulatory changes.

This has been one of the busiest weeks of regulatory changes in recent memory. Last week, the U.S. Department of Health and Human Services (HHS) issued its fourth amendment to the Declaration of the Public Readiness and Emergency Preparedness (PREP) Act. The press release read that this amendment “authorizes healthcare personnel using telehealth to order and administer covered countermeasures, such as a diagnostic test that has received an EUA (emergency use authorization) from the FDA (Food and Drug Administration), for patients in a state other than the state where the healthcare personnel are already permitted to practice.” 

So, does this solve telehealth licensure issues for patients being treated out-of-state? I don’t believe it’s a get-out-of-jail free card, because it looks like it only applies to covered countermeasures, but it’s another shield, and a seemingly good one, against an attack. When it comes to out-of-state practice, there are no guarantees, and it is important for licensed professionals to understand it is their risk, much more than their organization’s.

New Anti-kickback Statute and Stark Law regulations also appeared in the Federal Register last week, anc can be found at these respective links: and This article will not address the anti-kickback regulations, because kickback safe harbors aren’t all that important. You don’t need to be in one, and most relationships aren’t. By contrast, the Stark regulations are enormously important. 

Some of the changes are good. Certain payments intended to promote value-based healthcare will now have protection, and the way the exception is worded will offer intriguing new options for hospitals to assist physicians, if they choose. There’s also a bit more flexibility for resolving minor administrative mistakes without the need for a refund. If payments to a physician in a given year are set in advance, consistent with fair market value, and under $5,000, the absence of a written agreement won’t doom you. But that exception has a crazy twist. One would expect that a $10,000 payment to a group owned by five doctors would be divided up and treated as a $2,000 payment to each doctor. In fact, the full $10,000 is attributed to each owner.  

There are also new limits. Physician group practices need to carefully review their compensation formulas. You must now treat all designated health service revenue the same way. You can’t split your imaging revenue based on professional productivity while splitting physical therapy evenly. In addition, services that are on the Designated Health Services (DHS) list but reimbursed by private payors are now considered to have the DHS designation, and you can’t credit a physician for them.

Then there’s the Medicare fee schedule online. There is lots of stuff in there, much of it good. The Centers for Medicare & Medicaid Services (CMS) will permanently allow certain non-physician practitioners to supervise diagnostic tests. Historically, only physicians could, although during the public health emergency (PHE), CMS opted to permit non-physician practitioners like nurse practitioners (NPs), physician assistants (PAs), and clinical nurse specialists (CNSs) supervise tests.

Maintenance therapy also may now be delegated to occupational therapy assistants (OTAs) and physical therapy assistants (PTAs).

Teaching programs located outside of a metropolitan area’s statistical area will now be able to have supervision provided via remote video. The exception doesn’t apply within metropolitan area’s statistical areas, however. It also doesn’t apply for surgical procedures performed through an endoscope or anesthesia.

The news on telehealth isn’t as good as some hoped, nor is it crystal clear. Basically, CMS has kicked the telehealth can down the road, explaining that statutorily, they can only allow telehealth in rural areas. The rules do permit most telehealth services that will be covered during the PHE to remain covered through the end of 2021, even if the PHE ends. But if the PHE ends before then, new rulemaking will be required to extend the telehealth coverage beyond the end of the year. In short, while many people think telehealth is here to stay, and I count myself among them, from a Medicare perspective, we’re counting our pixels before they broadcast.

An example of the complexity: the rule creates a new G code permanently, allowing telephone visits to determine the necessity for an in-person visit. However, while many telehealth waivers are extended through the end of 2021, it seems that this one is not, and the current telephone exception will end with the end of the PHE. That brings me to the danger of relying on summaries of the law. My colleague Katie Ilten was recently trying to understand the end date for telephone coverage. She read a summary from a well-known firm and quickly realized that it was wrong. Be hesitant to fully trust summaries, including mine.

A random final observation: CMS indicated that remote physiologic monitoring is not a diagnostic test. As a result, an independent diagnostic testing facility is not permitted to allow it. That certainly surprised me.

If you need some reading material for the long nights at home during the pandemic, the government is doing the best it can to provide some. This will be my last article of 2020. Here’s hoping that 2021 is much less stressful year.

Programming Note: David Glaser is a permanent panelist on Monitor Mondays. Listen to his live reporting when Monitor Mondays returns on Monday, Jan. 11, 2021, 10 a.m. EST.

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